Successfully treated?"It was further discussed and agreed that Theralase would potentially be eligible for Breakthrough Therapy Designation (“BTD”) and / or Accelerated Approval (“AA”), if Theralase can demonstrate clinically significant results (high safety profile and high efficacy response), similar to the safety and efficacy results observed in the Phase Ib NMIBC clinical study (high safety profile and 67% CR) at an interim analysis of approximately 20 to 25 patients enrolled and successfully treated.”
It could be argued that none of the first 12 patients were successfully treated. After all, as we were informed in the July 30, news release:
"...all 12 patients being undertreated by the Study Treatment from between 30.9% and 154.3%."
The company has not mentioned this possibility but if one begins the count of successfully treated patients at patient 13, we would still have to treat 16 more patients to achieve the first 20 successfully treated patients. If the company took this approach there would be another delay of a few months, but BTD and accelerated approval would become a virtual certainty.